Details for New Drug Application (NDA): 208768
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NDA 208768 describes POSACONAZOLE, which is a drug marketed by Aspiro, Eugia Pharma, Fresenius Kabi Usa, Gland, Mylan Labs Ltd, Ph Health, Hikma, Actavis Labs Fl Inc, Aet Pharma, Amneal, Aurobindo Pharma, Biocon Pharma, Dr Reddys, Hetero Labs Ltd Iii, I 3 Pharms, MSN, Qilu Pharm Hainan, Sinotherapeutics Inc, Specgx Llc, and Westminster Pharms, and is included in twenty NDAs. It is available from twenty-eight suppliers. Additional details are available on the POSACONAZOLE profile page.
The generic ingredient in POSACONAZOLE is posaconazole. There are twenty-one drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the posaconazole profile page.
The generic ingredient in POSACONAZOLE is posaconazole. There are twenty-one drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the posaconazole profile page.
Summary for 208768
| Tradename: | POSACONAZOLE |
| Applicant: | Ph Health |
| Ingredient: | posaconazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 208768
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POSACONAZOLE | posaconazole | SOLUTION;INTRAVENOUS | 208768 | ANDA | Endo USA, Inc. | 42023-195 | 42023-195-01 | 1 VIAL, GLASS in 1 CARTON (42023-195-01) / 16.7 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 300MG/16.7ML (18MG/ML) | ||||
| Approval Date: | May 25, 2022 | TE: | AP | RLD: | No | ||||
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